PMS-TRAMADOL-ACET TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

N02AJ13

INN (International Name):

TRAMADOL AND PARACETAMOL

Dosering :

325MG; 37.5MG

Legemiddelform:

TABLET

Sammensetning:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0250601001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-02-08

Preparatomtale

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-TRAMADOL-ACET
Tramadol Hydrochloride and Acetaminophen Tablets, House Standard
37.5 mg tramadol hydrochloride
/ 325 mg acetaminophen
OPIOD ANALGESIC AND CENTRALLY ACTING ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
September 27, 2022
SUBMISSION CONTROL NO: 264215
_pms-TRAMADOL-ACET Product Monograph _
_Page 2 of 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT
INFORMATION.......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS................................................................................................
19
DRUG INTERACTIONS
................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE
..............................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY...........................................................
33
STORAGE AND STABILITY
........................................................................................
41
SPECIAL HANDLING
INSTRUCTIONS......................................................................
41
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 41
PART II: SCIENTIFIC INFORMATION
..........................................................................
42
PHARMACEUTICAL INFORMATION
...................................